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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002371
First received: November 2, 1999
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 80
Study Start Date: June 1996
Study Completion Date: December 1997
Primary Completion Date: December 1997 (Final data collection date for primary outcome measure)
Detailed Description:

Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • At least six months of prior cumulative ZDV therapy.
  • Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
  • Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days).
  • Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening.
  • Inability to tolerate oral medication.
  • Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

  • Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
  • Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.

Patients with any of the following prior conditions or symptoms are excluded:

  • History of acute or chronic pancreatitis.
  • Prior history of bilateral peripheral neuropathy.
  • Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry.

Prior Medication:

Excluded:

  • Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).
  • Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
  • Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
  • Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.

Risk Behavior:

Excluded:

  • Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.

Required:

At least 6 months of prior cumulative ZDV therapy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002371

Locations
United States, California
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Florida
Univ of South Florida
Tampa, Florida, United States, 33612
United States, New York
SUNY at Stony Brook / Division of Infectious Diseases
Stony Brook, New York, United States, 11794
United States, Texas
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, United States, 77006
United States, Utah
Univ of Utah / School of Medicine / Div of Infect Dis
Salt Lake City, Utah, United States, 84132
Canada, Ontario
Sunnybrook Health Science Ctr
North York, Ontario, Canada
Canada, Quebec
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec, Canada
Puerto Rico
Univ of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: . . .
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002371     History of Changes
Other Study ID Numbers: 244B, AI455-048
Study First Received: November 2, 1999
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HIV-1
Drug Therapy, Combination
Stavudine
Lamivudine
RNA, Viral
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Indinavir
Lamivudine
Stavudine
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014